skip to main content
Close Icon We use cookies to improve your website experience.  To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy.  By continuing to use the website, you consent to our use of cookies.
Global Search Configuration

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-four new guidance documents were posted to the tracker since its last update.

 

 

 

 

 

Forty-four new guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight's Guidance Tracker in the last two months (from Oct. 12 to Nov. 30).

 

 

The US FDA issued 12 guidelines since the last update, including a final document explaining when to submit a 510(k) for a software change to an existing device. While the guideline is helpful, an industry expert believes it does not do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight. (Also see "Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied" - Medtech Insight, 17 Nov, 2017.)

 

 

The updated list also includes a draft guideline from the Saudi Food and Drug Authority outlining the procedure that local manufacturers and authorized representatives should follow to address field safety notices (FSNs) issued in relation to their devices.

 

 

The updated list of new guidance documents is below. The full Medtech Guidance Tracker is online.

 

 

Medtech Guidance Tracker: October-November 2017

 

Key:

WHO: World Health Organization

HC: Health Canada

EMA: European Medicines Agency

NBOG: Notified Body Operations Group

HPRA: Health Products Regulatory Authority

MDA: Medical Device Authority

FDA Philippines: Food and Drug Administration Philippines

Saudi FDA: Saudi Food & Drug Authority

HSA: Health Sciences Authority

MCC: Medicines Control Council

Swissmedic: Swiss Agency for Therapeutic Products

MHRA: Medicines and Healthcare products Regulatory Agency

FDA: Food and Drug Administration

Read also

  • In Vivo: strategic insights for life sciences decision-maker...

    The Rise of Digital Tools eBook

    Explore how digital technologies are being used to address the disruption of clinical trials for drugs and medical technology caused by COVID-19. Stay current with insights from industry leaders, information on guidance and regulation, and an examination of how the challenges of this global crisis and the industry’s response to it may soon usher in a new era in worldwide healthcare.

    Topics Coronavirus

  • HBW Insight: Health, Beauty and Wellness, Generics Bulletin,...

    Pharma Intelligence Launches Alexa Skill

    Keep up with topics you care about in Pharma and Medtech with the new Alexa Skill from Informa Pharma Intelligence. Now you can listen to our podcasts on subjects you choose, right from your Alexa smartphone app!

    Topics $name $name $name

  • Medtech Insight: global medical technology news & analysis

    Refined FDA Analysis Report Finds 2 Fewer Deaths Linked To Essure

    By Sue Darcey 17 Sep 2020

    In a 15 September update of adverse events from Bayer’s now-defunct Essure birth control device, the US agency tallies patients’...

;

Next steps

Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.

Our team is always happy to hear from you. Please call us at:

  • US Toll-Free  : +1 888 670 8900
  • US Toll           : +1 908 547 2200
  • UK & Europe : +44 (20) 337 73737
  • Australia        : +61 2 8705 6907
  • Japan              : +81 3 6273 4260

Or please submit your inquiry via the form so that we can provide you the best possible customer service.

Have an immediate and specific information need?

Browse and buy from 1000s of analysis and research reports now: